DRT · Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cardiovascular · 21 CFR 870.2300 · Class 2
Overview
| Product Code | DRT |
|---|---|
| Device Name | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 338)
Showing 20 most recent of 338 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252676 | The Circadia C300 System (C300) | Circadia Health, Inc. | Feb 3, 2026 | SESE |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | Jan 28, 2026 | SESE |
| K251364 | Sleepiz One+ (2.5) | Sleepiz AG | Jul 29, 2025 | SESE |
| K234003 | The Circadia C200 System | Circadia Technologies, Ltd. | May 30, 2024 | SESE |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | Murata Vios, Inc. | Mar 22, 2024 | SESE |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | Feb 9, 2024 | SESE |
| K223163 | Sleepiz One+ | Sleepiz AG | Aug 18, 2023 | SESE |
| K212143 | Neteera 130H/131H Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | Sep 28, 2022 | SESE |
| K202138 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | May 14, 2021 | SESE |
| K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | Apr 26, 2021 | SESE |
| K181165 | Philips wearable biosensor-G5 Solution | Connected Sensing- A Division of Philips Medical Systems | Mar 7, 2019 | SESE |
| K172586 | Vios Monitoring System Model 2050 | Vios Medical, Inc. | Jun 22, 2018 | SESE |
| K170828 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | May 17, 2017 | SESE |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | Ivy Biomedical Systems, Inc. | May 27, 2016 | SESE |
| K150992 | Vios Monitoring System | Vios Medical, Inc. | Dec 16, 2015 | SESE |
| K121860 | ESA615 | Fluke Biomedical | Jan 25, 2013 | SESE |
| K121722 | ESA620 ELECTRICAL SAFETY ANALYZER | Fluke Biomedical | Oct 11, 2012 | SESE |
| K110429 | PROSIM 4, PROSIM 6, PROSIM 8 | Fluke Biomedical | Sep 2, 2011 | SESE |
| K110987 | CARDIAC TRIGGER MONITOR | Ivy Biomedical Systems, Inc. | Jul 22, 2011 | SESE |
| K103336 | MPS450 MULTIPARAMETER SIMULATOR | Fluke Biomedical | Apr 13, 2011 | SESE |
Top Applicants
- Hewlett-Packard Co. — 20 clearances
- Litton Medical Electronics — 17 clearances
- Ivy Biomedical Systems, Inc. — 10 clearances
- Life Science Instrumentation, Inc. — 10 clearances
- Nihon Kohden America, Inc. — 10 clearances
